Manufacturer's Devices - Irvine Biomedical Inc. a St. Jude Medical Company
Address:
2375 Morse Avenue
Irvine
California 92614
United States
Authorised Representative/ UK Responsible Person
Name: Abbott Medical UK Limited
Address:
Elder House Central Boulevard
Blythe Valley Business Park
Solihull
West Midlands B90 8AJ
England United Kingdom
| Code/Term |
|
Type |
| Intracardiac ultrasound imaging catheter steerable single-use | Intracardiac ultrasound imaging catheter steerable single-use | Class III
|
| Cardiac ablation system irrigation tubing set | Cardiac ablation system irrigation tubing set | Class IIa
|
| Bedside infusion pump single-channel | Bedside infusion pump single-channel | Class IIb
|
| Electrical-only medical device connection cable reprocessed | Electrical-only medical device connection cable reprocessed | Class I
|
| Electrical-only medical device connection cable reusable | Electrical-only medical device connection cable reusable | Class I
|
| Cardiac mapping catheter percutaneous single-use | Cardiac mapping catheter percutaneous single-use Conformity Assessment Certificate Expired | Class I
|
| Cardiac radio-frequency ablation system catheter | Cardiac radio-frequency ablation system catheter Conformity Assessment Certificate Expired | Class III
|
| Cardiac radio-frequency ablation system catheter | Cardiac radio-frequency ablation system catheter Conformity Assessment Certificate Expired | Class III
|